BEAUTIBOND
Agent, Tooth Bonding, Resin
SHOFU DENTAL CORP.
The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Beautibond.
Pre-market Notification Details
| Device ID | K082744 |
| 510k Number | K082744 |
| Device Name: | BEAUTIBOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Contact | David P Morais |
| Correspondent | David P Morais SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-18 |
| Decision Date | 2008-12-11 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23517820 | K082744 | 000 |
| E23517810 | K082744 | 000 |
Trademark Results [BEAUTIBOND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BEAUTIBOND 77575762 3667742 Live/Registered |
Shofu, Inc. 2008-09-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.